Guest Columns
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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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Notable Public Comments On The FDA’s Proposed Regulation For Laboratory Developed Tests
3/12/2024
The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.
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6 Things Medtech Companies Should Know About The EU’s AI Act
3/4/2024
With the recent publication of the European Union’s long-awaited Artificial Intelligence Act (AI Act), the message to medtech companies is clear: you need to move toward compliance by understanding your AI systems, determining their role under the AI Act, and identifying the specific obligations and implementation strategies that apply.
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New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis
2/29/2024
On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
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Rapid Diagnostics And The Quest To Develop The Fabled Star Trek Tricorder
2/23/2024
Fans of Star Trek will recall the tricorder, the small gadget routinely carried by Dr. “Bones” McCoy. In the world of medtech and diagnostics, talk inevitably turns to the ongoing, yet elusive, search for such a multidisciplinary diagnostic device. This article shares efforts that have been made in recent years and some practical considerations.
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A Successful Technology Strategy for Medical Device Teams Asking, “Own Or Partner?”
2/16/2024
Rapid innovation in medtech is a breakthrough that scales. One way to move forward faster is to have the right technology strategy to decide what to do — and what not to do. A solid technology strategy gives you confidence in what to tackle yourself, what to partner on, and what to buy off the shelf.
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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
2/16/2024
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
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Using Relational Risk Analysis To Control Procedure Failures
2/15/2024
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
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The Future Of Early Disease Detection: Breath-based Screening & Diagnostics
2/14/2024
Breath-based diagnostics is emerging as a promising technology, offering a rapid, painless, and non-invasive alternative to conventional methods. Like any emerging technology, it has both challenges and promise. Let's take a closer look.
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Understanding Australia’s Regulatory Framework For SaMD
2/12/2024
In 2021, Australia's Therapeutic Goods Administration implemented reforms covering a wide range of software, including software as a medical device (SaMD) with the goals of clarifying the scope of regulated software products, introducing new classification rules, and updating the principles governing software-based medical devices.